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2026년 8월 1주차 규제뉴스

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, Your firm's written procedure designates the pharmacist as responsible for ensuring the accuracy of compounding records and performing quality checks requiring pharmacist verification. However, your firm's compounding record does not specify container and closure to use to ensure they are adequate for its intended pharmaceutical usage. For example: your firm manufactured Gabapentin 100 mg/mL Suspension Stock Solution Lot 656519 that may be used in the production of patient-specific drugs. This stock solution can be stored for up to <Redacted B4> per the compounding record. The compounding record for Gabapentin 100 mg/mL Suspension Stock Solution Lot 6S6519, used in the production of patient dosage Lot 657408, does not describe the container and closure system in sufficient detail. The record states only "Bottle with Insert and Dosing Syringe." without specifying the material or type of container. This level of detail is inadequate to ensure that the selected container and closure system is appropriate for long-term storage of up to <Redacted B4> and does not provide sufficient assurance against degradation due to leaching, permeability, or inadequate sealing over the

EM!'I.O~SI S IGNATIJftf DATelMUED

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Specifically, EMPU>YEE(S) SIGMT\JRE CV.ll:i lSSU'Sl)

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

Specifically, Your firm performs routine potency testing only on in-process materials for Levothyroxine Sodium and Liothyronine Sodium. Your firm does not perform routine finished product testing on manufactured drug products. For example: A. Trilostane Capsule 58 mg Lot 660349 (RX# <Redacted B4>) Your firm did not perform identity or strength testing on this finished drug product prior to release. Conformance to the labeled potency of 58 mg was not analytically verified; release was based solely on theoretical potency calculated from the quantities of components used during production. B. Gabapentin 100 mg/mL Suspension Lot 657408 (RX# <Redacted B4>) Your firm did not perform identity or strength testing on this finished drug product prior to release. Conformance to the labeled concentration of 100 mg/mL was not analytically verified; release was based solely on theoretical potency calculated from the quantities of stock solution used during production. The stock solution used, Gabapentin 100 mg/ml Suspension Stock Solution Lot 656519, itself was not tested for its potency after the production. EMPl.0-.a!(SI SIGHA T\JRE DATliilSSUED

There is no written testing program designed to assess the stability characteristics of drug products.

Specifically, Your firm does not have written stability testing program to determine the beyond use date for each drug product. Your firm assigns beyond use date based on the <Redacted B4>, which is based on either stability testing performed by other entity for in-process stock, or based on the dosage form and the storage condition. *DATES OF INSPECTION 7/06/2026 (Mon), 7/07/2026 (Tue), 7/08/2026 (Wed), 7/09/2026 (Thu), 7/10/2026 (Fri), 7/13/2026 (Mon), 7/14/2026 (Tue), 7/15/2026 (Wed), 7/16/2026 (Thu), 7/17/2026 (Fri) ,_... ..

The written stability testing program is not followed.

Specifically, stability samples intended for long-term stability studies are not identified accordingly. For example: During the inspection of stability sample room intended to store stability samples under long-term storage conditions i.e., 25°C/60%RH, numerous stability samples of o@ OXe) were observed. The site initiated long-term (25°C/60%RH; for 36 months) and accelerated (40°C/75%RH; for 6 months) stability studies for this batch in March 2023 as per Stability Protocol KK-P-03-F29.04. It was observed the stability conditions were not identified on many sample labels. For example, if such sample is swapped from long-term stability chamber to the stability chamber intended for accelerated samples; it could not be detected. It was observed the firm had only one sample in the stability chamber marked for 36-month testing. The stability samples are tested by in-house QC Lab as well as by the third-party contract testing lab. The firm management failed to provide reasonable explanation how one sample can be tested by both laboratories that involves microbial evaluation as well.

Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards ofidentity, strength, quality, and purity.

Specifically, A. Your microbiological identification method used for confirmatory identification of 44 ww and other specified microorganisms in finished drug products, raw materials, and we has not been validated or verified for its intended use. Your firm uses the @ microbial identification system qm System) for confirmatory identification of microorganisms; however, you have not qualified the y4, System to identify all organisms routinely tested as part of your firm's microbial limit testing (MLT) including: A.1l. Your firm's wm testing procedure requires ww testing for &@ and subsequent confirmatory identification on positive samples using the» System. During the inspection, all 4) 4

All records of production associated with a batch of drug product were not maintained at least one (1) year after the expiration date.

Specifically, Your firm failed to retain electronic audit trail data generated by manufacturing equipment for the required period, failed to establish procedures for the review of audit trail data, and failed to ensure that audit trail review results in investigation of manufacturing anomalies. A. Electronic audit trail data for all,«5 and SOME 4 «) equipment is permanently deleted after one year. Drug products manufactured on these machines carry a typical shelf life of » | »@ As aresult, audit trail data is being destroyed while product manufactured on these machines remains on the U.S. market within its expiration date. There is no assurance that the complete manufacturing history for distributed drug product lots can be reconstructed or verified. Approximately @« batches of drug products have been manufactured using these pieces of equipment since 2024, with audit trail data permanently deleted while products remain within expiry on the U.S. market. Examples include but are not limited to: Finished | Product name Mfg. Mfg. Exp Date Shelf Final Dest. goods Batch no | Date Life in Code — (OFC)

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

A. i | Equipment ID: 4 re Manufacturing Suite) On May 13, 2026, during the inspection of the gw Manufacturing Suites. — Tablet Block, @ residues were observed on the g« of the a a (Equipment ID: we following a Non-Serial Changeover (NSCO) — product-to-product cleaning — after the manufacture of g Capsules gy mg (Batch No: gw with the equipment status label indicating "Cleaned." Your firm's Work Instruction No. F1/WI/PT/103/R2, titled "Operation and Cleaning of ©©® " (Sectiong~ |— Non-Serial Cleaning), requires complete dismantling of all components including the wets OO) oe until no traces of previous product are observed, and IPQA verification ofcleanliness in dismantled condition prior to reassembly and use, as documented in Cleaning Checklist F1/WI/PT/103/F-01/R1. B. Hie | Equipment ID: @« | en Tablet Block On May 13, 2026, during the inspection of the g)4» area of the Tablet Block, 4 residues were observed on top of the HEPA filter housing located on the technical floor » unit of the

Your firm failed to exercise controls over computerized manufacturing equipment to ensure that only authorized personnel can create and modify recipes, that obsolete or unauthorized recipes cannot be selected for commercial manufacturing, and that accurate data input is maintained across your facility's computerized systems.

Specifically, A. Multiple obsolete and unauthorized recipes exist simultaneously on gw equipment with no functional mechanism to prevent their selection during commercial manufacturing. Obsolete and unauthorized recipes were observed on the following equipment: o©@ wo) Oe Your firm acknowledges that obsolete recipes cannot be deleted from equipment due to system limitations. These obsolete recipes remain accessible to production supervisors during batch manufacturing, creating risk for incorrect recipe selection across multiple product lines and manufacturing areas. For example, youtga equipment 9 used for manufacturing 9 ow tablets contains numerous obsolete recipes for the same product code gw including versions sitet that are marked obsolete but remain selectable on the Human Machine Interface (HMI) for 4 Additionally, other equipment, such as we containsnumerous unauthorized recipes that are selectable during commercial production, including recipes named after specific batches such as iil Re Your firm's procedures acknowledge this limitation but do not provide compensating controls to prevent incorrect recipe selection during manufacture of commercial

Each component is not tested for conformity with all written specifications for purity, strength, and quality.

Specifically, Your firm failed to performg testing, including the limit test for « © (NMIp@ %), Nw each shipment of each lot of high-risk drug components prior to their use in manufacturing drug products distributed to the United States market. SOP GQC/022/R09, effective . mandated @«) testing for g in high-risk components. Despite this requirement, the firm's practice, both before and after the SOP effective date, was to test only4 sample rather than 9 ©@® testing results were not recorded in the firm's LIMS. This failure was not detected by the firm's quality system for the following raw materials: A. ae USP (Material Code 4) ww testing for»« __Was not performed on lots ofi USP received prior to g . despite the applicable FDA guidance having been issued ing) — representing a gap of approximately 4 Furthermore, this failure continued after the SOP effective date: lot 4) 4 received after 4«) , was tested by g) sample only;

Laboratory records do not include complete data derived from all tests, examinations, and assay necessary te assure compliance with established specifications and standards.

Specifically, A. Environmental monitoring (EM) samples were documented in Logbooks as collected but were not actually taken. Specifically, on 02/19/2026 we inspected the Quality Control Pharma (QCP) Microbiology Laboratory. We inspected EM samples under incubation. We noted the following. 1. Plant-@ injection line aseptically fills products for the U.S. market. 5. 14, Plante ISO 5 active air samples were documented as collected in Logbook LB/QCP6/26/005-01 from 08:06 to 10:44 on 02/16/2026 during 45 «ay ‘Injection Batch 4)oy (domestic market) sealing activity. According to the Logbook record, these samples were under 20-25°C incubation from 02/16/2026 to 02/19/2026. However, on 02/19/2026 no samples were found in the laboratory incubator. Your QCP personnel confirmed these samples were never collected. In addition, we reviewed Plant® filling line (non-U.S.) EM records. Plant-© aseptically fills oy¢ OG) products. On 02/19/2026, we reconciled Plantg@) EM samples under incubation and found the following. ®

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

Specifically, A. While observing a mock aseptic fill on February 24, 2026, the following deficiencies were noted: 1. Operators were observed obstructing unidirectional HEPA-filtered air flow over the stopper bowl and aie vials while refilling the stopper bowl 2, Operators observed obstructing unidirectional HEPA-filtered air flow by passing forceps over the4) wa 2nd removing fallen vials from the 4,4, 3. Operators observed obstructing unidirectional HEPA-filtered air flow while moving,, vials from the 4,4, loading area to the 4,i» loading area through the4, (by (4) 4. Sterile forceps inside the holder had falien over onto the bottom surface ofthe ,. The sterile forceps tips touched the surface and were placed back upright and used for subsequent interventions. — EVPLOYEE(S)

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

Specifically, Your firm's deviation management system is inadequate and does not capture equipment issues that may affect product quality. Since March 2024, your firm has created approximately 50 service work orders in Plant © for critical manufacturing equipment, including but not lumited to Ow O@ Your firm did not initiate deviations for several of these equipment issues. According to firm management, deviations are only initiated for equipment malfunctions that occur during production that have an immediate product impact. Equipment issues are frequently identified and corrected solely through the service work order system and not evaluated through your deviation process. This practice is inadequate because: e Equipment malfunctions are not assessed for potential impact to product quality regardless ofwhen they occur (set up, during production, etc.) e Issues are not tracked, trended, or investigated to identify root causes « Corrective and preventive actions (CAPAs) are not implemented or verified for effectiveness e Your firm cannot ensure that critical manufacturing equipment remains in a qualified and validated state Examples of service work orders with no corresponding devi

The responsibilities and procedures applicable to the quality control unit are not in writing.

Specifically, Your firm has not established written procedures defining the quality control unit's responsibilities and authority. Standard operating procedures describing the quality control unit's role and scope of authority were not available during the inspection. As a result, personnel were unclear about their specific duties and decision-making responsibilities within the quality control function.

The quality control unit lacks the responsibility and authority to approve, reject all drug products.

Specifically, a) Manufacturing operations are currently proceeding without qualified Quality Assurance (QA) oversight present during critical process steps. This deficiency includes a lack of real-time review and approval of critical process parameters and deviations by qualified QA personnel. Additionally, there is insufficient QA involvement in batch record review during active

Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, drug product closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

Specifically, From 06/02/2024 to 05/05/2025, your firm released @@ lots of m@ products to the US market without conducting required microbiological testing, including testing for m™@ 0) All your @@ products contain »@ an inactive ingredient in the formulations, which significantly increases the microbiological risk profile and necessitates comprehensive microbiological testing to ensure product safety.

Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Specifically, From 06/02/2024 to 05/05/2025 your firm released@@ _ lots ofm@ products to the US market. These lots were manufactured usinge@ as an inactive ingredient. At the time of manufacturing, you accepted thew based on the supplier's Certificate of Analysis (COA) and failed to conduct specific identity analysis for each lot, which should include a limit test for m@ and incorporates testing of samples from all containers of all lots. For example wm@ Lot # w@

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

Specifically, Your firm currently assigns expiration dates based on the packaging date of m@ products rather than the compounding date, which fails to account for the actual age of the bulk product and potential degradation during storage. Your firm proposes ag@ expiry period from packaging. For example, @@ lot # m@ was compounded on m@ but not packaged until») (approximately m@ later), yet was assigned an expiration date of ©) 4) effectively giving it nearly »@ total shelf life from compounding

Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.

Specifically, From 06/02/2024 to 05/05/2025 your firm released m@ lots ofm@ products to the US market without conducting adequate hold time study. Following are examples of lots released without adequate hold time studies

Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.

Specifically, Equipment used for the manufacture of Positron Emission Topography (PET) drug products including (b) (4) injection, are not adequately maintained and in good state of repair. For example, during my observation ofthe hot cell cleaning and aseptic manipulation in the hot cell ((b) (4) ) on 17Mar2026, I observed the following: 1. The interior of the hot-cell door’s lead-shielded glass exhibited breakage at two corner locations (top and bottom), with sections of glass missing from each corner anda risk assessment has not been conducted to assess the impact of the missing glass sections on the identity, strength, quality, or purity of PET drug products. 2. Chipped paint and rust were observed on the hinges and surfaces of both the hot cell's main door and side door. The missing glass sections of hot cell and its peeling surface pose a risk of contamination to the PET drug product manufactured within this hot cell. The firm has manufactured and released into commercial distribution approximately© @batches of(b) (4) injection using this equipment in the last 12

Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.

Specifically, A. Test procedures for performing bacterial endotoxin testing lack adequate instruction to prevent variability in sample handling that could produce inconsistent test results. For example, on 03/05/2026: e the operator performing quality control endotoxin testing for PET drug.(b) (4) (b) (4) ), Batch Number (1) (4) prepared the sample (D) (4), which then sat for approximately ® minutes prior to loading into the® @)test cartridge. The operator did not the (b) (4) after sitting nor before testing. e the operator performing quality control endotoxin testing for PET drug, (b) (4) Batch Numbei(b) (4) prepared the sample (b) (4), which then sat for approximately(®) (4) minutes prior to loading into the © test catridge. The operator (®) (4) the sample (Db) (4) by(b) (4) after sitting and immediately before testing. Per SOP D008421 Product Testing: Bacterial Endotoxin Test -© Method the sample (b) (4) isa (6) (4) of final product solution and sterile (Db) (4) . The procedure fails to instruct a(b) (4) method, ”x time duration, or testing time frame after (b) (4). B. There is no quarantine period for Final Product Vial (FPV) subassemblies to ensure they were

You did not follow written quality assurance procedures.

Specifically, On 03/05/2026 following production of ®@Fpvs, (b) (4) __., in the ISO 5 Laminar Flow Hood, performing operator failed to collect EM personnel glove samples as instructed in written procedure, D00011940 Preparation of Final Product Vial Subassembly — (b) (4) . The procedure instructs operators to (BD) (4) ” (©) 4) clove finger on to surface of sample media. On 3/5/2026, the operator was observed (Db) (4) fingertip onto media surface.

The responsibilitics and procedures applicable to the quality control unit are not fully followed.

Specifically, 1) Failure to provide required cGMP training Your firm did not provide current Good Manufacturing Practice (CGMP) training to employees in 2024 and 2025. According to Section 5.10.1 of SOP-HR-002, CC#25-0139, annual cGMP training is required for all employees, including temporary workers. 2) Inconsistent application of quarantine and approved material labels Quarantine tags and QA-approved labels are not applied uniformly to material containers and pallets. According to Section 5.1.6.1 of SOP-PR-016, CC#25-0141, quarantine tags must be attached to each pallet or individual container. According to Section 5.7.4 of SOP-QA-116, CC#25-0139, approved labels (printed on (6) (4)paper) must be affixed to each component container and to each pallet for other materials. During the facility walkthrough on February 23, 2025, not all material containers or pallets in quarantine rooms () and had quarantine tags, and not all material containers/pallets in excipient room © had QA-approved labels.

The written stability testing program is not followed.

Specifically, Your firm has not performed temperature mapping studies for the (6) (4) _ stability chamber (Serial Number

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.

Specifically, During this follow-up inspection, I found that your firm has failed to correct deficiencies cited in December 2023 regarding inadequate cleaning validation and procedures for shared equipment used in drug product manufacturing. Your firm continues to manufacture over-the-counter (OTC) (b) (4) soap, (b) (4) (b) (4) (b) (4) and (b) (4) drug products using the same equipment utilized for manufacturing non-pharmaceutical industrial detergents and disinfectants in your facility. My review revealed the use of shared equipment with draft versions of cleaning validation protocol and procedures. The following filling operations are examples for shared equipment for manufacturing of pharmaceutical and non-pharmaceutical products. Filme ProneSid

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Specifically, A. Inadequate Cleaning Controls Your firm has not approved cleaning procedures for the manufacturing equipment used for (b) (4) (b) (4) soap, and (b) (4) gel drug products. For example, cleaning procedure, KM-WI-018, Working Instruction for Cleaning and Sanitization for (b) (4) Filling lines® and& has not been approved. This procedure specifies that overall cleaning steps should take between (b) (4) to (b) (4) However, my review of Form KM-FO-010, Log for Cleaning and Sanitization of Production Lines, effective date 11/08/2024 found that on 02/28/2025, a major cleaning of (b) (4) was performed in (b) (4) on filling line 8 . This filling line was subsequently used for filling (©)(@) lots of (b) (4) into final packaging

Drug products failing to meet established standards, specifications and quality control criteria are not rejected.

Specifically, A.Your firm received (b) (4) USP (b) (4) lot (b) (4) , on 10/06/2025. This lot of (6) (4) was used as a component in the manufacture of "” finished (6) (4) based drug products for a total of (b) (4) units released to the market. My review of the bulk lot manufacturing orders found that preparation of (b) (4) was performed using calculations based on the (b) (4) component being (b) (4) instead of the actual (b) (4) concentration. There was no modification of the ingredient volumes to compensate for the difference in (b) (4) Laboratory records for these bulk lots showed the following results and examples of finished lots

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Specifically, A.Your firm failed to have approved written procedures to execute and has not executed all the responsibilities of the quality control unit to produce drug (b) (4) gel, (b) (4) and (b) (4) I found no approved procedures for the quality and laboratory systems: _JAnnual product reviews, qualification of employees, investigations, corrective and preventive actions, stability, process validations, batch numbering system, and out of specifications (OOS) investigations. B.Your firm failed to follow procedure QM-PR-002, Registry Control, effective date August 2021. A total of 8 batch records of (b) (4) and (b) (4) were not available for review during the inspection. C.Your firm does not have a proper drug product label control. My review found that there is no established procedure for handling and securing drug product labels. On 02/17/2026, I observed the label storage area gate was open and drug product labels were not locked for authorized personnel only. D.Good Documentation Practices are not being followed as stated in procedure QM-PR-006, Good Documentation Practices-GDP, Effective Date: 11/162022. It was observed overwriting, cross- outs without initials, dates and c

Complaint records are deficient in that they do not include the findings of the investigation and follow- up.

Specifically, Your firm failed to follow procedure MM-PR-002, Complaints Procedure, effective date 05/05/2021. My review of the complaints found that your firm kept a list of the complaints that lacked critical information including product name, lot number, root cause analysis, conclusions, and assessment of impact to other lots. Additionally, no investigations were initiated for the complaints selected during this inspection. e Complaint 2025-08-15 was initiated on 08/15/2025 after a customer reported that (b) (4) (b) (4) labeling was missing lot number and expiration date. Your firm resolved the complaint by sending © employees to the client location to replace the deficient labels. Upon my request, you identified the affected lot as (b) (4). This lot was part of a campaign of” lots manufactured in June 2025. e Complaint 2025-10-10 was received on 07/10/2025 after a customer found particulates inside of (b) (4) finished product containers. Your firm resolved the complaint by providing a refund and replacing the defective bottles with new (b) (4) bottles. eR eS | gee |

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.

Specifically, Ab) (4) __Limit Test Your firm failed to have a written and validated test procedure for the determination (Db) (4) ‘in the raw materials like (b) (4) and (b) (4) . Test method used for the evaluation of (b)(4) _—in (b) (4) and (b) (4) has not been validated and detection of (b) (4) using non-validated instrument also has been done since January 2025 for the release of these raw materials. In addition, data collected for the linearity test done on 01/27/2025 was stored in the instrument under (b) (4) while the instrument was acquired by the firm on January 2025 as per Work Order #54636 (OT ID#6134).

Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.

Specifically, 1) Your firm failed to implement laboratory mechanisms to prevent analysts from submitting edited or modified raw data obtained during routine analytical tests. Specifically, a) During inspection it was found that calibration record for the pH meters (4(b) (4) ) used at the QC laboratory for the release of raw materials and finished products were not verified for accuracy from period of 09/Feb/26 up to 16/Feb/26 as evidence for data collected during the inspection on 02/17/26. Even though, on 02/19/26 the same record was modified by adding initials authorizing the calibration data by the firm Chief Executive Officer (CEO) that accepted the modification of record during wrap up meeting on 02/19/26. b) During review of raw data generated by Density meter (b) (4) (S/N (b) (4) ‘+d used for the evaluation of raw materials and finished products to determine specific gravity, density and (b) (4) a raw data modification was made. For example, (b) (4) (lot #(b) (4) - (b) (4) tested on 10/02/2025) and (b) (4) (lot # (b) (4) tested on 9/25/2025) it was observed that instrument test results reports were generated on 2/24/2026 while these batches were released back in 2025. 2) Fai

There is no written testing program designed to assess the stability characteristics of drug products.

Specifically, Your firm failed to support established expiry date indicated in the product label for the manufactured products due to lack of stability program (Protocols, Specifications, Sampling Plan, etc.) to support it. a)The finished products stored in a small room does not represent stability storage conditions

Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.

Specifically, Reserve samples from representative sample lots or batches of drug products are not selected by acceptable statistical procedures and are not examined visually at least once a year for evidence of deterioration. Specifically, your firm lacked written procedures with statistical approach during reserve sample collection. Only (b) (4) collected in a(b) (4) test tube instead of product marketed

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.

Specifically, Your firm has not established sampling and microbial test methods for (b) (4) (b) (4) Soap, and (b) (4) Gel, including the detection of Burkholderia cepacia complex (BCC) in your finished products.

Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.

Specifically, Your firm used laboratory instruments for the release of raw materials that has not been qualified. a. The analytical balances (#(b) (4) ) used during analytical tests were not fully qualified while using a non-certified weight mass of (b) (4) —_. No determination of weights at the operational range, no centering, etc. to ensure reliability of sample and standards weights collected from

The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

Specifically, You firm failed to sample and perform identification testing to the components of each drug product prior to using it. The untested components received were (b) (4) , lot (b) (4) and (b) (4) , lot (b) (4) from suppliers to produce (b) (4) (b) (4) and (b) (4) Gel products. For (b) (4) , lot (b) (4) , your firm failed to provide receiving records and Certificate of Analysis during the inspection. This observation is repeated from the previous inspection in December 2023.

Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.

Specifically, During our initial walkthrough of the facilities on 02/17/2026, we observed that the facility and equipment is not maintained in a good state of repair, clean, or organized. For example: A.No sufficient space between pallets of packaging components, such as bottles and lids, causing accumulation of materials in the production area. B.The production room is exposed to the exterior because the rolling door at the loading and unloading dock, with direct access to both production and warehouse areas, was observed completely open. The filling line is approximately (BD) (4) away from the rolling door. C.Non-dedicated hoses were found uncovered and lying on the floor. Two hoses were observed open and on the floor in the pharmaceutical and non-pharmaceutical production rooms, with stagnant water containing cleaner observed approximately one foot away from the hoses. Moreover, the (b) (4) hose used for the addition of(6) (4)to pharmaceutical and nonpharmaceutical products was observed uncovered and lying on the floor. D.During the warehouse visit, we observed bird drops, dead lizards, and dead flying insects in top of boxes. Some of these boxes contained components such as lid

Investigations of an unexplained discrepancy anda failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.

Specifically, During the investigation (LAB-00433) initiated on February 6, 2026, for an out-of-specification (OOS) (b) (4) result obtained for (6b) (4) , USP, Receiving Lot #(b) (4) (Retest Date: (b) (4) ), you determined that the root cause was the aging of the (Db) (4) =material, which decreases (b) (4) over time. (BD) (4) Lot #(b)(4) —_-was subsequently rejected. However, this same (Db) (4) lot had previously been used while meeting in-house (b) (4) limits at the time of use to manufacture the following finished product batches that were released to the market: e Bulk Batch(b) (4) - Filling Batch (b) (4) -—(b) (4) Batch(b) (4) ((b) (4) ; Manufacture Date: (b) (4) ; Expiry Date: (b) (4) ) e Bulk Batch(b)(4) - Filling Batch (b) (4) —(b) (4) Batch(b)(4) ((b) (4) ; Manufacture Date: (b) (4) ; Expiry Date: (b) (4) ) The investigation concluded that the associated drug product batches were not impacted because the (b) (4) material met in-house (b) (4) limits at the time of use and the finished product batches passed drug product specifications at release. However, the investigation was not extended to evaluate

The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.

Specifically, The number of containers to be sampled and the amount of material to be taken from each container for (b) (4) and (b) (4) testing of high-risk components is not based upon appropriate criteria. Specifically, your sampling procedure (SOP No. NL-QA-017.12) does not include a written scientific or statistical rationale for the amount of sample collected from each container for(b) (4) _ testing of high- risk drug components. You collect approximately (6)(4) per container; however, there is no documented justification establishing that this quantity is appropriate relative to container size or sufficient to perform all required testing, including repeat testing. Additionally, your written procedure does not establish criteria requiring that each individual container of each lot of high-risk drug

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, Excel spreadsheets used to perform GMP calculations, including system suitability assessments and analytical result calculations for HPLC analyses, were observed to be unvalidated and executed outside ofyour validated (b) (4) — system. Specifically, the following spreadsheets were observed in use: e (b) (4) SysSuit.xlsx — HPLC system suitability for (b) (4) e (b) (4) SysSuit.xlsx — HPLC system suitability for (b) (4) analysis e (b) (4) _BU_Calc.xlsx —(b) (4) bulk calculation e (©)(4)_ASCU_Calculation.xlsx— Assay/content uniformity calculation e (b) (4) _AS Calc.xlsx —(b) (4) assay calculation e (b) (4) _ASCU_Calculation.xlsx — Content uniformity calculation e (b) (4) Disso calc.xlsx — Dissolution calculation e (b) (4) CU By® @xlsx — Content uniformity calculation e (b) (4) BU Calc.xlsx — Bulk calculation e (b) (4) As Calc.xlsx — Assay calculation e (b) (4) Calculation.xlsx — Assay calculation e (b) (4) _Calce.xlsx —(b) (4) calculation e (b) (4) _Calc.xlsx — (b) (4) calculation e (b) (4) _DS_Calculation.xlsx — Dissolution calculation e (b) (4) _Calc.xlsx — Content uniformity calculation

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Specifically, You failed to conduct a cleaning validation study to demonstrate that your cleaning procedures effectively remove penicillin residues from equipment that is used to repackage both penicillin and non- penicillin drug products. (A) From June 2023 to August 14, 2025, Bulk ® Packager, Bulk Packager, Bulk® Packager, Bulké Packager, and Bulk Packager were used to repackage approximately (b) (4) _ solid oral doses of drug products, of which approximately (b) (4) doses involved penicillin products. Your cleaning procedure for bulk packager was not established based on a cleaning validation study to assure effective removal of penicillin residues to prevent cross-contamination with non-penicillin drug products. (B) From June 2023 to August 14, 2025, the (b) (4) _—was used to repackage (b) (4) lots of drug products, ofwhich"® lots involved penicillin products. You did not performa cleaning validation study to establish a detailed cleaning procedure for the (Bb) (4) _ to assure effective removal of penicillin residues to prevent cross contamination with non-penicillin drug products.

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Specifically, From August 01, 2024, to August 12, 2025, your firm identified 750 defects but did not investigate them to determine root causes. In addition, you lack adequate written procedures for investigating discrepancies to determine whether corrective action or extension of the investigation to other lots is required. For example: (A) Defect ID 11880 identified a discrepancy regarding a unit dose that was distributed to a hospital containing two different tablets. (B) Ten defects identified as having “foreign particle packaged” were not investigated to determine the source of the contaminant. These include Defect ID: 11510, 11511, 11619, 11680, 11839, 12126, 12171, 12183, 12202, 12203.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

A. On December 5", 2025, while observing set-up onw@ Filling Line (Room @@ for the aseptically filled finished drug product m@ batchm@ poor aseptic processing behavior was observed. This filling line is used to manufacture US market product. Examples ofpoor aseptic behavior include: 1. An operator exited the filling room and returned with m@ for the mw filling apparatus, these m@ in total) are affixed to this filling apparatus in close proximity to aseptic connections, approximately m@ 2. Operators were specifically observed moving freely between Grade A and Grade B spaces without any record of their movements and activities throughout the entire setup process. 3. Operators were observed with exposed skin while performing maintenance activities on thes@ «assemblies in close proximity to the filling station and / or while performing aseptic connection. 4. Operators were observed wearing safety glasses with exposed skin around the glasses. In addition, operators were observed moving their protective eyewear (glasses) such that they rested on their forehead while their head was inside the Grade A area. 5. Operators were observed reaching into the open bag containing sterile bottles mu

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

A. Personnel monitoring program has not been implemented for any aseptic operations. Personnel monitoring regarding aseptic connections has never been conducted. B. Surface monitoring has never been performed on any equipment surfaces including critical product contact surfaces such aso® product contact locations including C. Active viable air sampling has never been implemented in any aseptic processing areas. SEE Lisa L. Flores, Investigator LLF 12/10/2025 REVERSE OF | Robert Ham, Investigator THIS PAGE XK )g ZL

Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

A. You do not perform visual inspection of your aseptically filled product, and you have not established written procedures regarding this critical process. Your QA Manager reported you inspect the outside of each unit for defects to include particles but do not inspect the contents. B. You lack control over critical elements of your terminally sterilized m@ process for the following: C. You lack recordation of critical process parameter(s) in your BPRs regarding your 0) process such that »@ is not recorded. Your production personnel reported@ was required form@ 1. Enumeration of rejects is absent regarding your in-process visual inspection of filled ow for your»@ process, instead, your BPRs read in part, “OK”. Furthermore, critical attribute of@ integrity is apparently incorporated into your SEE Lisa L. Flores, Investigator LL a 12/10/2025 REVERSE OF | Robert Ham, Investigator THIS PAGE OW FORMFDA 483 (09/08)

The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed.

A. You do not document quality system events such as deviation, OOSs and changes. 1. No deviations or OOS were generated for the EM/PM deficiencies nor for any discarded QC records identified during the inspection. 2. w@ testing forms changes were made approximately »@ per Microbiology 6 . : Manager, subsequently causing you not to collect over m@ samples. No Change control nor other quality record was opened to capture this event. 3. You performed a change to your method validation for your @@ on o@ and did not document this revalidation via any change control. B. At the initiation of this inspection on December 3, 2025, we found GMP documents that were disposed inside a bag which was inside a box collected from QC Documentation Room © The evaluation of the contents of the bag revealed presence ofg@ Analysis sheets from XC) =. ,@@ validation data summary sheets from 2019, certified copy of the validation certificate for the Bacteriological Incubator from 2022. Other items in the bag included vials ofm@ Injection USP, unlabeledm@ wo) containing aH@ liquid, unlabeled vials containing a»@ liquid, among other scraps ofpaper. 1. Logbooks m@ Testing Lob Book and Bulk Sample Testing Log

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Specifically, Your investigations relating to Out of Specification (OOS) and Out of Trend (OOT) investigations are not thoroughly investigated and the CAPA taken is inadequate to determine the risk to the drug products sold into the US market. For example, A. Your OOS and OOT investigations for @ USPw@ ml, anda @ mla@ alae are not thoroughly investigated. For example, OOS Investigation Number: 157370, Date of Initiationg)@ , Product: @ @ USP a@ ml a@ Batch Number: g @ , Mfg. date: a @ , Expiry date: g@ Stability Timepoint: 6-month long term stability condition (25°C/60%RH), Shelf life of product: @a Issue: Related Substances by HPLC test found OOS test result for individual unidentified impurity (due to an unknown peak at RRT about@@ Result: @@ %, Limit: NMT@@ %, Investigation conclusion: Valid/Confirmed OOS. Your Quality Unit reported Field Alert (FAR/A/24/010) ong to the agency but this annual stability batch @@ was not recalled from the US market upon confirming OOS at 6-month stability timepoint. This batch failed again at 12-month stability time for the same individual unidentified impurity at RRT about @ @ (Result: aya %) On @@ . Your firm initiated OOS investigation number 1

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, Your Quality Unit lacks adequate oversight into the integrity of data pertaining to QC testing on UV Spectrometry. For example, On 23-Apr-2026, the evaluation of Dissolution by UV test data revealed potential for lack of testing integrity. Your QC Analyst appeared to have analyzedg)@ separate test samples on UV Spectrometer ing@ However, when the same analyst demonstrated the analysis for the same product during the inspection on 23- Apr-2026, the analyst appeared to be rushing to complete the analyses and still ended up taking twice the amount of time i.e. about @ @ fora@ test sample. Few examples are included as follows: Table 4 b)@) Unnee Ranjan, DDC Investigator UNNEE RANJAN -S RANA

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Unnee Ranjan, DDC Investigator UNNEE RANJAN -S RANIAN-S

Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.

Specifically, Your manufacturing operators do not initiate deviation investigations after identifying out-of-specification (OOS) results during in-process testing of tablet formulations duringg~@ = —~—_—operations. A review of raw data from in-process testing revealed that several batches had failed in-process test results. No manufacturing deviations or documentation in the executed batch records were available for these failures. Your firm follows a similar approach for capsule products as well. Additionally, the Quality Unit’s review performed as part of batch release did not initiate deviations for these OOS in-process results. A review of approximately (@ batches revealed that aboutm@batcheswe %) had failed in- process test results for which no deviation investigations were initiated. There is no assurance that products manufactured meet established in-process control requirements. For example, this is not a comprehensive list: Table 7 _ 7 . . Digitally signed by UNNEE RANJAN Unnee Ranjan, DDC Investigator U f ~ Se MERE 14:59:52 40530 |

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Specifically, a) On April 20, 2026, during inspectional walkthrough of Building ® which is utilized for the manufacturing of om products for the U.S market, the following was observed: Unnee Ranjan, DDC Investigator UNNEE RANJAN -S5 soasosar eos sae

Aw@ -Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

Specifically, Your procedures relating to complaint investigation (CQA/0153-008, Effective date: 30-Sep-2024), and Field Alert (CQA/0191-003, Effective date: 31-Jan-2025) are deficient. There is no information relating to impact assessment and market actions that need to be taken in the event of repeated market complaints received for the same product and batch number. For example, Digitally signed by UNNEE iN ef DL INI ON — a Unnee Ranjan, DDC Investigator JINN Date: 2026.05.01 15:02 +0530

Deviations from written production and process control procedures are not recorded and justified.

Specifically, a) On April 20, 2026, during thea)@ operation of w@ Tablets USP @@ mg, batch 0) thegy @ had an in-process limit of 0) (4) Theg a) documented in the batch manufacturing record was wq@ However, upon verification using the ow (Equipment # g@ used for the batch, the actual q@ was found to be ow Based on the manufacturing operator, it was unknown why theg@ was out of the specified in-process limit. He also stated that, during the previous interval, he had recorded a lower value than the actual @ @ displayed on the aya b) On April 20, 2026, at 12:32 PM, thea operation ol) Tablets USP, batch q@ was placed on hold due to failure to achieve the aw required by the batch manufacturing record. The production supervisor stated that engineering was notified of the machine issue via phone call. The tablets Unnee Ranjan, DDC Investigator _ aN ANAS i

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

Specifically, a. Your firm does not perform any finished product testing (including but not limited to testing for contamination of objectionable microorganisms and assay) for drug products intended for the U.S. market other than checking for conformance to appearance and weight per unit specifications. There is no written documented agreement that testing and other GMP activities not performed by the firm is to be done by the customer, and that shipment is done so under quarantine. In 2025, your firm has manufactured and distributedm@ the following drug products intended for the U.S. market: ©)

The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

Specifically, Your firm does not perform identity testing for components used to manufacture drug products intended for the U.S. market. Components without identity testing performed include but are not limited to: OS) These components are the active pharmaceutical ingredients for O@ YC) drug products intended for the U.S. market.

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Control procedures are not established which monitor the output and validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product.

Specifically, Your firm has not validated the production processes used to manufacture the over-the-counter finished human drug products intended for the U.S. market: (OS)

There is no written testing program designed to assess the stability characteristics of drug products.

Specifically, Your firm does not perform stability testing for drug products intended for the U.S. market. There is no written documented agreement that stability testing is to be performed by the customer. Additionally, your firm does not have any data to demonstrate drug products intended for the U.S. market meet their established specifications throughout their labeled shelf-life of no longer thane we In 2025, your firm has manufactured and distributed m@ the following drug products intended for the U.S. market

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Specifically, Your firm has not validated your cleaning procedures and UV-Vis test method to demonstrate that cleaning of shared equipment is effective and reproducible at removing drug product residue and other contaminants that could adversely affect the quality of drug products intended for the U.S. market. Additionally, shared equipment used to manufacture drug products intended for the U.S. market wo) @ ® is cleaned using @@ that has not been demonstrated to meet or exceed appropriate @@ standards.

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.

Specifically, Your firm did not include specimens or copies of all completed labeling, including the label adhered to the m@ packaging bottle and labeling on the m@ packaging carton, in your batch production records for packaging finished over-the-counter human drug products intended for the U.S. market. Your firm did not include specimens or copies of full labeling in each of the respective batch packaging ; . : . . wa records for the following finished drug products: XC)

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

Specifically, sample containers used to collect endotoxin test samples, including finished drug substances, are not made of suitable materials to ensure reliable and accurate results. The firm uses sample containers made of we to collect endotoxin samples for batch release testing and held up to @@ __prior to testing. No endotoxin recovery studies were performed to verify suitability of the sample containers, and to ensure Ory container surfaces do not interfere with the endotoxins in the sample. Endotoxins g@ are known to have affinity to adhere to @ materials, potentially resulting in false negative results.

Input to and output from the electronic records and data are not checked for accuracy.

Specifically, electronic test records fromg@ ‘Integrity Testy units are not reviewed or reconciled against the printed test reports and failed test results are not always identified or reported in the associated batch production records. Failedg integrity test reports are not always printed or included in the associated batch production records and not reviewed to ensure compliance to written retesting requirements. The written test procedure allows maximum Of@@ integrity tests petgyg ’, including gq re-tests after initial failed test result. Following failed gq) reports obtained from the stored electronic data were observed to be missing from the production batch records for ga) dug substances, Batch# q : A. Initial failed gq results for g @ on the drug substances ga) Filling operation was not

Laboratory testing procedures lack sufficient testing requirements to ensure accurate and scientifically sound determination of the test materials.

Specifically, there are no incubation time requirements listed in the written procedures to initiate the growth test for exposed biological indicators, Iincubation time requirements are not listed in theg@ qualification protocol/report and exposed biological indicators were not placed on test for extended period of time. Biological indicators from aay qualification performed on@@ were not placed on test until m@ ! approximately @@ _ later. ww is used to perform sterilization on production equipment components, including the @@ assembly used during for the @@ drug substance filling operation.

Written production and process control procedures are not followed in the execution of production and process control functions.

Specifically, during the execution dug substances manufacturing, Batch# @@ required pre- production environmental monitoring (EM) was not performed as specified in the procedure #SOP- XMS-8000.MF, including Airborne Viables and Non-Viable Particle monitoring of the production Laminar Flow Hood. Pre-production EM for the batch filling operation was performed during @@ ow prior to drug substances filling operations. As stated in the written procedure, pre- production EM is required to be performed duringg)@

Written procedures are not established for the cleaning and maintenance of equipment used in the manufacturing, processing, or holding of a drug product.

Specifically, equipment cleaning procedures do not include drying procedures or designated equipment holding area to prevent residual liquid solution@ ‘from dripping into the classified production area. During the walkthrough of the production area, recently cleaned production @@ tank (equipmenttt @@ 1300) was observed dripping liquid into the classified area (Grade D), pooling under the equipment. This recently cleaned equipment was staged in the production corridor with the@@ _-valve in open position to drain. Liquid ga in the classified area could potentially allow proliferation of microorganisms, including bacteria and mold.

Laboratory controls are inadequate to ensure reliable analytical testing of critical quality and safety attributes.

Specifically, Critical analytical methods showed high invalid assay rates froma@ to current: m@ fora @@ ALaboratory Investigation Report (LIR) has been initiated, and operator training was identified as the main root cause. While some methods have shown improvement following enhanced training programs O@ invalid rates for the following critical analytical methods remain high in @@ for o@ @@ |!n addition, invalid rates are also high fotg@ iNey

Laboratory investigation procedures for Out of Specification (OOS) results are inadequate.

Specifically, In WX-SOP-10217: Laboratory Investigation Report Procedure, Section 5.5.9.1, states: "If no root cause is identified through phase 1 and 2 investigations, upon consultation with QA, the investigation may progress to retesting.". Section 5.5.9.5 specifies: "If all results meet specification, are within system suitability and sample acceptance criteria the re-testing can be reported and the original analysis invalidated.". This SOP allows retesting and subsequently invalidate the original results if no root cause has been identified, which is inappropriate. When no clear laboratory error has been identified, the initial results may constitute valid analytical findings that should be reported and considered in the batch release decisions. SEE

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Specifically, A) No process validation has been performed for OTC drug product(BYG@YY, USP O® Tablet), which is not in accordance with the firm’s established written procedure, SOP-25 “Process Validation” which requires validation of processes to confirm that a process consistently produces products that meet predetermined quality and safety standards. Two lots of(4), Usp (P Tablet) were manufactured and released in (®)@). B) On 01/14/2026, our observation of tablet compression for(BYP) Lot HB) revealed a lack of batch records on the production floor to ensure consistent batch manufacturing and contemporaneous documentation of production activities. Upon request of the blending and compression batch records for(6) (4) Lot A{BY),, the Blending Operator provided incomplete batch records which did not include any batch identification, preventing traceability.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

Specifically, No Bulk hold time studies have been conducted for blend. During the facility walkthrough on 01/13/2026, we observed blended (B)(4)) Lot (Blended on (6)(4)) stored in the manufacturing area corridor prior to beginning compression on (b) (4) . On (b) (4) compression of(B)(4)) Lot #(6)%4)) was paused due to supposed sticking and breaking issues encountered during the compression process. Compression operations for (6)(4)) Lot AB)(4) resumed on (b) (4); however, compression was suspended again on the same date due to a supposed oil-related issue with the equipment. Compression activities remain on hold pending repair of damages to HEPA filters observed in the Janet A. Rajan

Batch production and control records do not include the specific identification ofeach batch of component and in-process material used for each batch of drug product produced.

Specifically, The batch records for OTC drug product(BA), USP @® Tablet) Lot # (BY) and Lot # (6)(4)) do not include the distinctive lot identification of the raw material (active pharmaceutical ingredients and excipients) used in the manufacturing of the drug product. FACILITIES AND EQUIPMENT SYSTEM

Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design and of adequate size to facilitate operations for its intended use.

Specifically, A) No Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) have been conducted for the Tablet Press(YAY (Room (YY Room) which was used in the compression of OTC drug product (B)@IIIII. UsP (P@ Tablet) manufactured in ®)@) to ensure the equipment is suitable for its intended use. B) The Installation & Operational Qualification (NYN-IQ/OQP-001) and Performance Qualification (NYN-PQ-001) for the packaging Line is deficient for the following reasons: 1. During the review ofbatch packaging records for the OTC Drug products listed in the table below, we observed that some packaging line setting parameters set during batch startup were not qualified during 1Q/OQ and some critical tests were not performed during batch start up: — Janet A. Rajan

Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.

Specifically, A) Your firm has not performed cleaning validation studies and established clean hold times and dirty hold times for equipment, including, but not limited to, the Mixing MachineHYG, used to manufacture both dietary supplements and drug products to prevent cross-contamination as required per SOP-26 “Cleaning Validation”. On 01/09/2026, the (B)(4)) for OTC drug product (6) (4) (no lot number was listed in the usage and cleaning logbook) was blended in Mixing Machine (6)(4) following the blending of dietary supplement (6)4Y I on the same equipment. B) Usage and cleaning are not always documented in the usage and cleaning logbooks for each equipment used to manufacture and/or package OTC drug products. Additionally, your firm uses a cleaning solution prepared with (B)(4)) and city water; however, the composition and preparation details of cleaning solutions used for cleaning equipment are not documented in the equipment usage and cleaning logbooks. In addition, the cleaning procedures do not include sufficient detail to ensure consistent cleaning. C) According to SOP-97 “Usage of (B)(4Y” and CAPA NYM-CAPA-25-008, the firm is required to perform (BYP swab sampling for clea

Buildings used in the manufacturing, processing, packing and holding ofa drug product are not maintained in a good state of repair.

Specifically, On 01/21/2026, visible damage and black/brown stains were observed on the HEPA filters on the ceiling in Compression Room ®#above the "Tooling Tablet Press(BA which was used to compress(BA) tablets Lot (BY). No preventative maintenance program exists for the HEPA filters. MATERIAL SYSTEM

Drug products are not stored under appropriate conditions of temperature, humidity and light so that their identity, strength, quality, and purity are not affected.

Specifically, A) No continuous temperature monitoring is conducted of the manufacturing corridor areas where drug products are held. During the facility walkthrough on 01/13/2026, we observed blended (BY4 Lot ABP) (Blended on ** ) stored in the manufacturing area corridor where temperature is only monitored(BH) using a (BYP) thermohygrometer. B) No temperature and relative humidity (RH) mapping studies were conducted during the summer for the warehouse where active pharmaceutical ingredients (APIs) and raw materials are stored. Additionally, the mapping studies conducted during the spring, fall, and winter are insufficient, as data collection was limited to (B)(4)) 9) within the warehouse with manual readings taken only(6) over (YAY) period preventing identification of hot and cold spots in the warehouse. In addition, there is no routine continuous temperature monitoring of the warehouse; a (B)4) temperature value is recorded (BY using a (GB) thermohygrometer. On Janet A. Rajan

Specific identification tests are not conducted on components that have been accepted based on the suppliers report of analysis.

Specifically, No comprehensive testing was conducted to establish the reliability of the API (HYG). USP vendor which is not in accordance with section 5.5 of SOP-20 “Vendor Qualification”. The SOP requires that “in addition to the questionnaire, a sample of the material supplied by the vendor in question will be tested accordingly”. SOP-20 lacks specific instructions regarding the number of material lots to be evaluated during vendor qualification/requalification and the types of testing required to verify vendor adherence to specifications. Additionally, at least one specific identity test for AP](5). USP is not performed routinely; according to the firm’s R&D Specialist, certificates ofanalysis from the vendor are accepted in lieu of identity testing for some batches. Per SOP-30 “Receiving & Storage of Raw Materials”, identification testing is mandatory for all incoming raw materials.

Procedures describing the warehousing ofdrug products are not established and followed.

Specifically, Materials stored in the warehouse are not appropriately labeled with their disposition status to prevent use of unapproved materials in manufacturing operations. On 01/16/2026, the Interim Production Supervisor stated that (B)(4) of API (OYA PN UsP in the warehouse were under quarantine status due to customer cancellation of the manufacturing order. However, during our walkthrough of the warehouse conducted on 01/16/2026, the respective(b)(4) duction Super, USP (b) (4) were not labeled to reflect its quarantine status. Additionally, the Interim Production Supervisor in icated that API (BYAIN (Vendor Lot (GAIN) had been released; however, the (BY) of AP! (BY) (6) (4) lacked appropriate labeling to identify its released disposition. Janet A. Rajan

Strict control is not exercised over labeling issued for use in drug product labeling operations.

Specifically, A) The room used to store labels of OTC drug products is not access controlled. During our walkthrough of the label room on 01/13/2026, rolls of(6/4) tablet drug product labels were observed in the label room. On 01/14/2026, during our walkthrough of the label room, these labels were no longer present. According to the Interim Production Supervisor, the labels had been packed for shipment and return to the supplier; however, there was no documentation in the Label Room Log to trace the movement of labels. B) Batch production records for OTC drug products, including but not limited to(b)(4) tablet Lot AYA), (6)4S tablet Lot HbA) andYA) WO tablet Lot AOA, lacked the following documentation: e Packaging and label reconciliation to ensure accountability of materials used in packaging and labeling operations. e Examination of packaging and labeling materials prior to packaging operations. e Lot numbers of packaging materials used in packaging operations on the material data sheet. DIETARY SUPPLEMENTS

Your batch production record did not include all required information.

Specifically, You manufactured(4G Tablet, Batch No #: (G)N4). which was distributed on 4/30/25. The following was observed: e The batch manufacturing record was not reviewed and signed off as closed. Janet A. Rajan

Your batch production record did not include complete information relating to the production and control of each batch.

Specifically, Your written standard operating procedure SOP No. 28 titled “Batch Manufacturing Record” states that a list ofraw materials used in the batch, including their sources, batch or lot numbers, and quantities would be included in the batch manufacturing record. However, the following was observed: es , and were used to manufacture your Tablet, Batch No #: There is no batch or lot numbers listed for these components in your batch manufacturing record, and you do not have any other documentation allowing you to identify the batch or lot numbers ofthe components to the Tablet, Batch No #: (BLA).CA Tablet, Batch No #: was distributed on 04/30/25. e (4 7,and Capsules were used to manufacture your (B)(4) Capsule, Batch No #: . There is no batch or lot numbers listed for these components in your batch manufacturing record, and you do not have any other documentation allowing you to identify the batch or lot numbers of the components to the(BY) Capsule, Batch No #: (BY). (G4 Capsule, Batch No #: (6)(4)) was approved and distributed on 04/28/25. Janet A. Rajan

For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met, and limits on contamination to ensure the quality of the dietary supplement.

Specifically, Specifications for purity, strength, composition, or limits on contamination have not been established for: - (4) = (4) e * Capsules Also, you use FTIR as the method to test for the identity of()(4Y) This is not an appropriate method to test the identity for (6)4) These components were used in the(BE) Capsule, Batch No #: (BY), which was approved and distributed on 04/28/25. Additionally, specifications for purity, strength, composition, or limits on contamination have not been established for: es Janet A. Rajan

You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.

Specifically, You manufactured(EA Tablet, Batch No #: (6)M4), which was distributed on 4/30/25. The following was observed: e You provided a certificate of analysis using Neeyaan letterhead dated 04/05/2025 indicating (b)(4) BatchNo: was used to manufacture ()(4) oe tab for Tablet, Batch No #: . You do not conduct testing in-house and use a third-party lab for testing. You do not have raw material testing records from the lab to demonstrate testing was erformed. In addition, there is no documentation to confirm (6/49) Batch No: @@ a was used to manufacture(BA Tablet, Batch No #: (BY). e You provided a certificate of analysis using Neeyaan letterhead dated 03-14-2025 indicating (o)(4) eS pore was used to manufacture (Oy) oe lab len Tablet, Batch No #: . You do not conduct testing in-house and use a third-party lab for testing. You do not have raw material testing records from the lab to demonstrate testing was erformed. In addition, there is no documentation to confirm Batch No: (b)(4) was used to manufactureog One Tablet, Batch No #: (b)(4) e You provided a certificate of analysis using Neeyaan letterhead dated 02-20-2025 indicating (62) NNN Batch No-(BY(@)NNE Ml was used tomanufac

Your quality control operations did not include determining whether each finished batch conforms to established product specifications.

Specifically, You manufactured(64) Tablet, Batch No #: (6)M4). which was distributed on 4/30/25. You provided a certificate of analysis using Neeyaan letterhead dated 05-22-2025. You do not conduct testing in-house and use a third-party lab for testing. You do not have testing records from the lab to demonstrate testing was performed. In addition, you manufactured (B)(4)IPIW Capsule, Batch No #: (6)§4)), which was approved and distributed on 04/28/25. You provided a certificate of analysis using Neeyaan letterhead dated 05-19- 2025. You do not conduct testing in-house and use a third-party lab for testing. You do not have testing records from the lab to demonstrate testing was performed.

You did not follow written procedures for quality control operations.

Specifically, Your written standard operating procedure SOP No. 41 titled “Finish Product Release & Distribution” states QA shall review and approve the release of finished products for distribution, with the review criteria including compliance with all manufacturing, packaging, and labeling procedures and specifications; satisfactory test results and inspection findings; and completed and approved documentation, including batch records and investigation reports. However, your certificate of analysis for(B)(4 I WE Tablet, Batch No #: (6)M4) was signed as approved on 05/22/2025, which is after the distribution date of 4/30/25. Janet A. Rajan

Your quality control personnel did not conduct a material review and make a disposition decision when a batch deviated from the master manufacturing record.

Specifically, You manufactured(BTA Capsule, Batch No #:(B)(4Y), which was approved and distributed on 04/28/25. The following was observed: e The batch manufacturing record shows the (percentage) % actual yield was 86.47%. The procedure states that ifthe yield or reconciliation falls outside the acceptable limits(5)(4} to promptly report the discrepancy to the supervisor and not to proceed with further processing until approval is received from QA. However, there is no documentation in your Out of Specification Logbook or Deviation Logbook.

You did not establish product specifications for identity.

Specifically, You manufactured (B)G4P I) Tablet, Batch No #: (6)(4). which was distributed on 4/30/25. Your finished dietary supplement product specification for identity lists (BYP as the method reference. The method states “Assay results are derived from the batch manufacturing record (BMR) as part of production and process control.” This is not a scientifically valid method.

You did not establish specifications to ensure that you applied the specified label.

Specifically, Finished dietary supplement labels are provided by your customers. You do not have specifications to ensure that you applied the specified label. Janet A. Rajan

You did not establish packaging specifications.

Specifically, You procure the packaging for finished dietary supplements. Packaging specifications were requested, and you stated that you do not have packaging specifications. *DATES OF INSPECTION 1/13/2026(Tue), 1/14/2026(Wed), 1/15/2026(Thu), 1/16/2026(Fri), 1/21/2026(Wed), 1/23/2026(Fri), 1/27/2026(Tue) Apouds Janet A. Rajan

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Specifically, Your firm's method validation reports foig@ Impurity testing of active pharmaceutical ingredients (API) and finished product form@ do not include documentation of analyses that failed to meet predetermined acceptance criteria, nor do they include the associated investigations and corrective and preventive actions. For example: A)Your firm’s method validation report titled, Method Validation for the Quantitative determination of oe impurity in ®® API , MV Report ID: iVRS-@@ -MV-24-001, Version: 02, Dated: 11 Nov 2024, does not include documentation of two analysis that failed to meet your predetermined acceptance criteria or the associated investigations and corrective and preventative actions. The method validation analysis that failed to meet acceptance criteria were conducted on 9/12/2024 for Linearity, Range, and Accuracy, and 9/13/2024 for Limit of Quantitation (LOQ) Accuracy. B)Your firm’s method validation report titled, Method Validation for the Quantitative determination of ® impurities in

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

Specifically, Your firm’s investigation, 1VRS-»@ -MV-029-INV-01, into seven analyses that failed to meet acceptance criteria as part of the method validation for your firm's in-house m»@ Impurity method, iVRS-STP-144, per Validation Protocol, iVRS-»@ -MV-029, was not thoroughly documented and failed to determine a specific root cause and associated corrective and preventive actions. Additionally, all seven failed analyses were re-analyzed between 4/22/2024 and 5/2/2024, which is prior to the documented initiation date of the investigation on 5/3/2024.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

The written stability program for drug products does not include reliable, meaningful and specific test methods.

Specifically, Your firm has not demonstrated that your in-house method, 1VRS-STP-144, is specific and appropriate for analyzing stability samples of finished drug product foig@ Impurities. Your method validation report, Method Validation for the Quantitative determination ofm@ oe impurities in oe OC) 0) ” MV Protocol ID: 1VRS-w@ -MV-029, Version: 01, Date: 04 May 2024, does not include supporting evidence or justification that your method is capable of accurately identifying and quantifying @@ impurities in the presence of other impurities, degradation products, and/or degradation excipients. Your firm has conductedm@ Impurity analysis on m@stability samples wo of oe finished product. On 12/18/2025, your firm’s customer confirmed these finished product samples are stability samples that are part of validation batches for we)

The responsibilities applicable to the quality unit are not fully followed.

Specifically. Since June 2023, approximately 4)1 batches of Ow | oa API were released to the market | without assurance that they had safety levels of oh ae Additionally, the quality unit failed to develop a Risk Assessment of the Presence Of, 1D He API, —

There is a failure to thoroughly review any unexplained discrepancy and the failure to of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed .

| Specifically, The quality unit failed to perform a thorough customer complaint investigation regarding, batches of§ 4 API that obtained 4 45 contents above the specifications | limits. The quality unit neither performed testing to the APIs to detect 4) | Ow nor established a corrective and preventive | action to avoid recurrence. These APIs were sent to the US market and other markets, _ | . ] SEE - J

Procedures designed to prevent microbiological contamination ofproducts purporting to be non-sterile | are not established.

Specifically, a, The quality unit fails to ensure that the contract laboratory that performs the testing for the | we system used for the manufacture of APIs (i.¢. ga ss | a and excipient, gu has | adequate and validated test methods. b. The quality control unit failed to ensure that the,4) system used for the manufacture | of APIs and excipient has safety level of5 | OBSERVATION 4 . The quality system to approve contract laboratories to perform microbiological testing of » « APIs, and excipients is deficient. | Specifically, | | 1, The quality unit fails to ensure that the approved contract laboratory used to perform testing of | APIs and excipient has the capabilities, equipment, test methods, knowledge, and reliability needed to perform the testing in an accurate and reliable way. 2. On December 11, 2024, the quality unit learned that since the year 2012, the approved: contract | laboratory performing the microbiological testing (i.e., Total Viable Count (TVC) and endotoxins) for the &a used for the manufacture of APIs and excipients neither has UKAS accreditation for the test requirements nor they conduct their analyses according to USP | or EP standard. At the time ofmy inspec

The accuracy, sensitivity, specificity, reproducibility, and reliability of microbiological test methods has not been established.

Specifically, { The quality unit fails to ensure that the microbiological test methods (e.g., TVC, pathogens identification, and endotoxins) utilized for the release of APIs [e.g., 45 (intended fordrug product). (intended for sterile injectable) and excipient 4) are validated.

The identity of each raw material of drug substance is not verified by conducting at least one test to | verify the identity , using specific identity test.

| Specifically, The quality control unit fails to establish a specific identification test method for g | a a raw material used for the manufacture of, API, | SEE OBSERVATION 7 The amount of material taken from each container is not based upon appropriate criteria. | Specifically, | The quality unit fails to ensure that the amount of raw material taken for testing is based upon appropriate criteria such as criticality of the material, material variability, past history of the supplier, | and the quantity needed for analysis. | | | | | | | | | | | | SEE

Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Specifically, I reviewed procedure title “Complaints” Doc# QA11-001R-SE, Edition 17, Dated: 09/22/2018 which specifies methods on how to receive, document, and process Complaints for your IMagiQ2 and Medstone tables. It was noted that the procedures do not adequately define on how complaint involving the possible failure of device to meet any of its specifications shall be reviewed, evaluated or investigated. I reviewed 11 complaints (Complaint C211006516, C211116576, C220104619, C220324717, C221004913, C221201998, C220815855, C2303011085, C2303011084, C2307051192, C232171075, C2305221142) and it was noted that three of the complaint (complaint# C211116576, C211006516 , C2307051192) investigation was not documented.

Procedures for acceptance of incoming product have not been adequately established.

Specifically, your incoming procedures titled “Ankomstkontroller och larger hantering (Arrival controls

A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.

Specifically, the firm failed to report the following field corrections conducted to reduce a risk to health posed by Micro-X Rover Mobile X- ray Systems: Service Bulletin, SB003-23 is issued to inform of a Micro-X Rover RV-35 firmware update addressing improvements to the software when exposing short pulse exposures. The documented risk is described as “there is a low probability that a Critical Error is reported to the operator during radiation exposures of a short pulse duration”. “If this Error is reported, a repeat exposure at different exposure techniques may be required to obtain necessary diagnosis”. Service Bulletin for the Micro-X Rover, SB002-22 is issued to inform of a field upgrade for the installation of an exposure switch holder on the Rover Mobile X-ray Units. The exposure switch holder attachment is to reduce the probability of the exposure button being pressed inadvertently while stored. Service Bulletin, SB006-23 for Micro-X Rover RV19, Micro-X Rover RV35 and Micro-X Rover RV80 is issued to inform of the correct process to switch between User profiles to reduce the risk of the on

Procedures for design change have not been established.

A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.

Specifically, the manufacturing process for Micro-X Rover RV71 that is marketed and distributed in the US has not been validated. The firm was unable to provide a documented justification for the decision not validate.

Procedures for corrective and preventive action have not been adequately established.

Specifically, Quality Event and CAPA procedure, SOP006 does not ensure that 1) sources of quality data are adequately analyzed to identify existing and potential causes of nonconforming product or other quality problems. 2) the firm failed to adequately identify the corrective actions for CAPA040-23 involving a reported malfunction of Rover Model: RV35.

Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Specifically, the complaints of reported malfunctions of the Micro-X Rover Mobile X-ray Systems are

The responsibilities and procedures applicable to the quality control unit are not in writing.

Specifically, your firm's written procedure SOP-05162, "Repackager Authorization to Ship," effective date December 8, 2025, is inadequate because it does not establish that the quality unit must review and verify the accuracy of variable data printed on finished drug product labels prior to release and authorization to ship. The procedure fails to require your quality unit verification of critical variable data including, but not limited to, lot number and expiration date, against the information reported on the Certificate of Compliance (CoC). Examples include, but are not limited to, your quality unit authorized release of: a. o® Capsules, USPo@ ng, lotw® expiration date m@ The signed associated Certificate of Compliance lacks documentation demonstrating that the quality unit verified the accuracy of variable data (lot number and expiration date) printed on the finished product labels against the CoC specifications. ©) @) _ b. Tablet, USP@®@ g, lotwe expiration date @@ The associated signed Certificate of Compliance lacks documentation demonstrating that the quality unit verified the accuracy of variable data (lot number and expiration date) printed on the finished product labels

Investigations of an unexplained discrepancy anda failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

Specifically, Your firm failed to expand investigation SCAR-000303 dated December 30,2025 to other lots after the root cause was identified as using a defective sealing process and material. Your firm received more 20 complaints between December 12, 2025, to March 3, 2026, reporting a similar inadequate blister seal strength for m@ Tablets, USP.» mg. ay The investigation only focused onw® Tablets, USFo@mg, Loto expiration date ©@ and ultimately led to a recall. However, the same process and materials were used across multiple lots and multiple products including but not limited to, Product Name |Major NDC #| Repackaged | # Saleable |Date Released| Expiration Lot # Units Date OG)

Your firm failed to have systems in place to enable compliance with the verification requirements ofthe DSCSA.

Specifically, your SOPs #04886, CAHPPL - Complaint Processing in Vault, effective October 21, 2025,

Deviations from written test procedures are not recorded and justified.

Specifically, Your firm’s SOP entitled, “(b) (4) Test using (b) (4) * Document No. G-WI- RAD-QA-335, Revision 3.0, Effective November 30, 2020, states that the “(b) (4) test” must be performed on the (b) (4) to ensure the instruments (6) (4) accuracy. Initial failures attributed to sample preparation errors may be repeated but a repeated failure requires a written “Calibration Investigation Report”. There were several initial and repeated (b) (4) test failures that were not investigated and/or documented. Instead, the analyst repeats the (b) (4) test until it passes. There is no written explanation/justification for this current practice. Furthermore, your firm relies on the data from the (b) (4) to release batches of drug products that have undergone (b) (4) sterilization and to provide your customers a Certificate of Processing stating that the drug products have achieved adequate exposure during the sterilization process. QUALITY SYSTEM

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, a) Your firm's SOP entitled, “Deficiency Handling”, Document No. G-WI-QA-002, Revision 14, Effective March 31, 2022 states that the Quality Control Unit is responsible for the timely completion of investigations however, your firm's Quality Control Unit (QCU) repeatedly failed to complete investigations of deficiencies (deviations & non-conformances) within the (b) (4) time frame with/without customer notification as written in your SOP. b) Similarly, your firm’s SOP entitled, “Corrective and Preventative Action (CAPA), Document No. G- WI-QA-005, Revision 15, Effective February 28, 2022 states that the QCU is responsible for closing CAPAs within a ®@ of initiation, However, your firm's QCU failed to close all corrective/preventative actions within the (b) (4) _ time frame as written in your SOP.

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

Specifically, Your firm's SOP entitled, "Customer Complaints", Document No. G-WI-CUS-001, Revision No. 16, Effective December 31, 2021 states that the Preliminary Investigation and Risk Assessment is to be completed as soon as possible but within (b) (4) of receipt of customer complaint. In addition, it states that the customer follow up is to be conducted a (6) 4) after the preliminary investigation/risk assessment is completed. However, at time of inspection, there were at least seventeen (17) open complaints that exceeded the time frame that have not been resolved.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Specifically, A)Your quality unit does not clearly document that data review is performed and verified as outlined in the Laboratory Documentation Checklist form prior to approval of the Finished Product Test Summary form for the 1) review ofelectronic raw data, including but not limited to high- performance liquid chromatography (HPLC), Ultraviolet—visible (UV-Vis) spectra, bacterial endotoxin testing (BET), and particle size analysis, 2) review of file or run level audit trails for laboratory instruments such as HPLCs, 3) verification of all calculations when excel worksheets are used, and 4) review and resolution of out-of-specification (OOS) or other laboratory non- conformances associated with chemistry or microbiological testing. B)Your quality unit does not document review of 1) (b) (4) standard checks for expiration date as outlined in SOP AR-SOP-0462 Receipt, Handling, and Storage ofReference Standards (version 11.0, effective 09/07/2022) and 2) the review of reagents and discarding of expired reagents from laboratory inventory as outlined in SOP AR-SOP-0437 Preparation, Documentation, and Storage ofSolutions, Mobile Phase, and Reagents (version 16.0, effective 07/16/2025)

Failure to obtain a complete investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation.

Specifically, at least three (3) domestic clinical sites were found to have consented and enrolled subjects under the (6) (4) portion of the Study Protocol (b) (4) without completing an updated form FDA 1572. These sites were initially activated under the (b) (4) _portion of the study (b) (4) and had completed a form FDA 1572 for (b) (4) . However, the sponsor failed to request an updated form FDA 1572 after the sites continued study participation under (b) (4) Although (b) (4) was executed as a protocol amendment, (b) (4) is described as a dose-ranging study in the protocol title whereas (b) (4) is not a dose-ranging study. In addition, the forms FDA 1572 that were completed for (Bb) (4) specified participation of the (b) (4) portion only. Therefore, the protocol titles and study objectives of(b) (4) and (b) (4) are different, and not all requirements of 21 CFR 312.53(c)(1) could be fulfilled without updating the form FDA 1572.

Failure to provide investigators with the information needed to conduct the study properly and ensure the study is conducted in accordance with the protocol and/or investigational plan.

Specifically, three (3) out of the fifteen (15) reported serious adverse events (SAEs) were found to have been reported by the clinical sites without providing the date of site awareness of the event. As stated within the clinical investigational plan ((b) (4) ), the clinical sites are to report SAEs directly into

Equipment shall be constructed so that surfaces that contact components, in-process materials, or medical gases shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.

Specifically, Your firm failed to provide adequate assurance that gasket particulate does not ingress into the container closure (e.g., tank) during filling operations. We observed (6) (4) gaskets used in the filling hose to connect to the shipping containers of the trailer trucks to be cracked and fractured. Your firm has not validated that the (b) (4) installed in the filling line is effective at removing all potential gasket particulates. No studies have been conducted to provide assurance that microscopic particulates (smaller than (b) (4) ) do not bypass the (5) (4) and contaminate the finished drug product.

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

During the inspection, your firm's laboratory operations were found to have significant deficiencies in data integrity, record maintenance, and analytical controls. Your quality control unit did not adequately oversee these operations to prevent systematic violations. Specifically: A) Inaccurate Laboratory Data: Review of records of over m@ finished product microbiology samples tested over oe revealed that 100% of the results were reported as "<10" (zero colonies) in laboratory records. However, during the inspection on January 12, 2026, investigator observed the presence of colonies on multiple plates during plate reading activities including two plates that were TNTC (too numerous to count) for the drug product m@ wo which was inconsistent with the documented trend. Your firm performs microbial release testing for US marketed OTC products including oe oe Additionally, @@ testing data exhibited repetitive number patterns for duplicate microbial m@ testing plates (example CFUs: m@ oe that suggest the data may not reflect actual analytical test results. Your facility uses m@ as a component in drug products, including »@ and multiple m@ as well as for cleaning of manufacturing equipm

Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.

Specifically, your cleaning validation program for non-dedicated manufacturing equipment, used for multiple drug products, is inadequate.

Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Specifically, During the inspection, batch manufacturing and analytical records for @ batches across @ products were reviewed: oe The following deficiencies were observed: A) Analytical data for residue on ignition and melting range tests recorded in BMRs and COAs did not match the corresponding entries in@@ analytical data books for O@

Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.

Specifically, during the inspection, it was observed that your firm has not conducted Annual Product Quality Reviews (APQRs) for the majority of products manufactured at @@ manufacturing units. While your firm provided APQRs for oe numerous other OTC drug products manufactured during the review period lack APQRs. Based on batch records reviewed, products missing APQRs include various m@ products manufactured at Unile@ Your firm's own SOP APQR (SOP/QA/014-06, Section 8.5) acknowledges this requirement, stating "Annual Product Quality Review shall be prepared for all products which are in the market oe

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.

Specifically, during the inspection conducted on [01/15 and 01/16/2026 ], the following deficient conditions were observed: a live bird and bird droppings were found in the raw material warehouse, approximately 30 feet from m@ packaging materials; apparent unidentified black substance was observed covering over 25% of the ceiling surfaces in both the raw material warehouse and finished drug product storage warehouse; and a gap approximately 1 inch was observed in the dock door of the finished product storage warehouse.

Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

Specifically, during the inspection conducted on [01/15 to16/2026], hoses connected to points of use in the Unite@ area and Unite manufacturing area were found to contain stagnant OY) compromising @@ quality and creating microbiological contamination risks. The ©) in these hoses is used for cleaning m@ tanks utilized in the manufacturing of drug products.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Specifically, A) Your firm failed to complete process validation studies for oe o@ manufactured at@@ as required bye@ B) Your firm lacks adequate controls over your stability testing program. Specifically, you do not maintain a complete inventory of stability samples under test nor establish procedures for reviewing stability data generated by o@

Process Validation performed does not demonstrate that critical process parameters produce consistent APIs meeting their specifications and quality.

Specifically, Your firm’s process validation for® USP,i product codes, does not include validation of processing times listed in the batch record and in procedure SOP# 149. For example®® 4) cycle minimum times in the batch record were not tested, function was not monitored or recorded, maximum and minimum loads are not defined for stress testing the process, anc) being held throughout the cycle is not monitored. In addition, your firm manually switches cycle ®® and?) operation rather than using recipes for repeatability. Your firm processed ®® product code batches and®® _ product code batches during process validation due to various significant deviations and OOS results, such as product Color, atypical Loss on Drying, Total Plate Count failures, and other issues. This caused your firm to make additional batches in order to achieve process validation criteria of three consecutive product batches meeting specification. Your firm has released approximately { out off} batches of®® product code produced in the past two years and (} out off} batches off} product code produced in the past two years. In addition, your firm’s procedure, SOP# 149, “Operating the®® ” states to (b) (4)

Supplier qualification do not include evaluations that provide adequate evidence that the manufacturer can consistently provide material meeting specifications.

Specifically, A.) Your manufacturer of has stated that “This product is unsuitable for use in the production ofAPIs as — do not follow required GMP practices and do not sell pharmaceutical grade products”. You proceeded to qualify this manufacturer of without obtaining a COA listing the identification and quantitation of all impurities as per the USP requirements. Additionally, you did not conduct a risk assessment to determine if this product would affect the quality of the final product. B.) Your firm has not completed additional testing of per USP standards at appropriate intervals since 2021 to assure that the manufacturer can consistently provide meeting specifications. C.) Your supplier of has not provided comprehensive certificates of analysis per USP requirements for every shipment/lot of received since 2021 and your firm has not checked and verified the reliability of certificates ofanalysis at regular intervals. | |

Batch records and laboratory records of critical steps are not reviewed and approved by the quality unit appropriately.

Specifically, A.) Your analytical laboratory paper records do not include signature and date ofthe second person reviewing ©@ impurity data on HPLC-1 for batches © ©) 4) These batches were later released by QA without investigating whether they were reviewed or not. In addition, your firm does not include an electronic signature of review for HPLC data. B.) Your microbiology laboratory paper records do not include the signature of the second person reviewing the record for accuracy including for growth promotion studies and finished product testing. C.) used in production of USP does not have user login and parameters on the ®@ can be changed by anyone with access to the room. Non- production personnel such as engineering, regulatory affairs, and quality assurance can access these controls. In addition, without user login there is no electronic traceability of operators performing manual cycle switches. D.) contain a shared administrator password for all users. This causes there to be no electronic traceability of operators performing manual cycle switches.

REPEAT OBSERAVTION FROM FDA 2019 INSPECTION***

There is an inadequate number of personnel to manufacture and test APIs adequately.

The stability program to justify assigned expiration or retest dates is not followed.

Specifically, Your firm has not placed any© USP®® batches on stability in 2024 or 2025. In accordance with your approved stability procedure SOP 021 Stability Testing of Bulk Drug Substances, Rev. S, Effective Date 12/22/2020, at least one batch per year is required to be put on stability. In 2024, pe USP batches, were released and in 20254} batches of USP, © were released. Lyw ws 09/29/2025